U.S. Food and Drug Administration Archives - Page 2 of 5

Can United Therapeutics turn pig-heart xenotransplantation into a regulated clinical pathway?

A pig-heart trial is no longer just a scientific leap. United Therapeutics now faces the harder test of safety, scale, and regulation.

HistoSonics has liver clearance. Kidney tumors are the harder test, where non-invasive ambition must meet regulatory and clinical proof.

Trelegy is a blockbuster, but complex inhaler generics are closing in. Transpire Bio’s FDA filing could test GSK’s respiratory moat.

Single-use catheters finally face a regulated reuse challenge. Aurie’s FDA De Novo win could shift urology device economics.

Rare cancer biology is becoming commercially actionable. BIZENGRI’s FDA approval puts NRG1 fusion testing under sharper scrutiny.

Social anxiety needs faster options. Vistagen’s fasedienol now faces the Phase 3 test that could make or break its nasal-spray thesis.

RNA editing just gained a liver cancer spotlight. Rznomics must now prove RZ-001 can turn early response signals into durable clinical value.

Mabwell has FDA clearance for 9MW5211. The bigger test is whether a first-in-class autoimmune antibody can prove durable remission.

Greener inhalers need more than lower-carbon chemistry. Aptar Pharma’s FDA-backed work tests the science regulators may need.

Trividia’s TRUE METRIX correction is no routine label fix. Glucose meter safety now hinges on software, usability, and upgrade execution.